Quality of Life Measures in Patients With Retinal Degeneration

NCT02814435 | Completed

• 1 other identifier: QoLMeasuresIRD
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision cases in the UK and starts at an early age. The purpose of this observational study is to use the results of two questionnaires and a computerised test testing contrast sensitivity, to assess the impact of IRD on quality of life. This study will involve collecting data from patients with IRD, but also collecting data from normal controls.

Conditions

Retinal Degeneration

Keywords

Retina; Retinal Degeneration; Quality of Life Measures

Outcome Measures

Primary Outcomes (1)

• Impact of inherited retinal degeneration on quality of life measures.

  This will be assessed by comparing questionnaire results between different inherited retinal degeneration types.This will be determined by using ANOVA testing to compare scores caused by different genetic mutations, allowing us to relate mutations causing central versus peripheral visual loss to the quality of life measures.

  May 2016 to May 2017

Secondary Outcomes (1)

• Effect of contrast sensitivity function on quality of life.

  May 2016 to May 2017

Study Arms (2)

Patients

Patients with inherited retinal degeneration will answer two questionnaires and undergo a computerised contrast sensitivity function test.

Other: Questionnaire; Other: Computerised contrast sensitivity function test

Normal controls

Normal controls recruited by advertising will answer two questionnaires and undergo a computerised test that assess contrast sensitivity function.

Other: Questionnaire; Other: Computerised contrast sensitivity function test

Interventions

Questionnaire OTHER

The participants will answer two questionnaires. These are the NEI VFQ-25 and the DLTV (daily living tasks of vision).

Normal controls; Patients

Computerised contrast sensitivity function test OTHER

This test involves the patient identifying whether bars on a screen are horizontal or vertical. It is designed to measure contrast sensitivity.

Normal controls; Patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 patients with inherited retinal degeneration will be recruited from the outpatient clinic in the Oxford Eye Hospital. 30 healthy controls will be recruited from advertising around the OUH hospitals and the University of Oxford.

You may qualify if:

• Participant is willing \& able to give informed consent for participation in the study.
• Male or female, aged 18 - 85.
• A clinical or genetic diagnosis of retinal degeneration or normal age and sex-matched controls without known retinal disease.
• Able to participate in visual function testing.

You may not qualify if:

• The participant may not enter the study if any of the following apply:
• \) they have a pre-existing amblyopia or squint;
• \) they have any other retinal problems that may confound the measures assessed.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford Eye Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Retinal Degeneration

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jasleen K Jolly, MSc

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

GB (1)